SCULPTURE 2.94 ER:YAG SYSTEM

K073158 · Hoya Conbio, Inc. · GEX · Aug 27, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073158
• Device Name: SCULPTURE 2.94 ER:YAG SYSTEM
• Applicant: Hoya Conbio, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows: Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece. Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies. The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.

Device Story

DermaSCULPT Er:YAG laser system delivers 2.94-micron infrared laser energy for dermatological soft tissue procedures. System console houses laser power supply, control unit, and calibrator. Physician operates device via footswitch; visible white light from flashlamp serves as aiming beam. Laser energy is delivered to tissue through fiber delivery system, handpieces, and optional scanner module. Device performs incision, excision, coagulation, and vaporization. Calibrator measures fiber transmittance; microprocessor controls laser emission parameters. Used in clinical settings by physicians to treat skin lesions, wrinkles, and scars. Benefits include precise tissue removal and resurfacing capabilities.

Clinical Evidence

No clinical data provided. Substantial equivalence established through review of technical characteristics, mechanism of action, and verification/validation testing (bench testing).

Technological Characteristics

Er:YAG laser system; 2.94-micron wavelength; flashlamp-pumped. Includes console, fiber delivery system, handpieces, and scanner module. Microprocessor-controlled. Electrical power source. Safety features include footswitch, safety shutter, and emergency stop. Non-fractionated and fractionated delivery modes.

Indications for Use

Indicated for dermatological soft tissue procedures including incision, excision, coagulation, and vaporization. Patient population includes individuals requiring skin resurfacing for wrinkles or scar revision (including acne scars), and removal of cutaneous lesions (e.g., nevi, keloids, verrucae, skin tags, keratosis, benign tumors/cysts, and diagnostic biopsies).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• CB Erbium 2.94 (K970934)
• VersaWave Dental Laser System (K041710)
• Multilite Erbium:YAG Surgical Laser System (K933057)
• Fidelis XS (K990243)
• CuteraPearl (K070138)
• Mosaic Laser System (K070392)
• Erbium Fractional Handpiece (K071768)
• Profile Multi-Platform System (K070388)
• SmoothPeel (K unknown)

Reference Devices

• Fraxel SR (K050841)

Submission Summary (Full Text)

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Ko 7 3158

AUG 2 7 2008

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Sculpture Er:YAG Laser System 510k Summary

Image /page/0/Picture/3 description: The image shows the logo for HOYA ConBio. Below the logo is the address 47733 Fremont Boulevard, Fremont, California 94538. The phone number 510-445-4500 and website www.conbio.com are listed, as well as the fax number 510-445-1550.

| Submitter: | HOYA ConBio, Inc.<br>47733 Fremont Blvd.<br>Fremont, California 94538<br>Phone: [phone]<br>Fax: [phone] |
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| Contact: | Mr. Jim Green<br>Vice President of Engineering |
| Date Summary Prepared: | July 21, 2008 |
| Device Trade Name: | DermaSCULPT Er:YAG Laser System |
| Common Name: | Dermatology Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX |
| Classification Code: | 878.4810 Laser surgical instrument for use in general and plastic<br>surgery and in dermatology (1) A carbon dioxide laser for use in<br>general surgery and in dermatology is a laser device intended to<br>cut, destroy, or remove tissue by light energy emitted by carbon<br>dioxide. (2) An argon laser for use in dermatology is a laser<br>device intended to destroy or coagulate tissue by light energy<br>emitted by argon. |
| Predicate (Equivalent)<br>Device: | CB Erbium 2.94 (K970934)<br>VersaWave Dental Laser System (K041710)<br>Multilite Erbium:YAG Surgical Laser System (K933057)<br>Fidelis XS (K990243)<br>CuteraPearl (K070138)<br>Mosaic Laser System (K070392)<br>Erbium Fractional Handpiece (K071768)<br>Profile Multi-Platform System (K070388)<br>SmoothPeel (K unknown) Laser Peel. |
| Device Description: | The DermaSCULPT Er:YAG Laser System [DermaSCULPT]<br>unit and controls are contained in a single console. Electrical<br>power is supplied to the console by the facility's power source.<br>The laser energy produced within the device is delivered to the<br>tissue by means of Fiber Delivery System and specially designed |

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## KO73158

Scanner, Handpieces, Tips and Adaptors.

| The user activates laser emission by means of a footswitch. The<br>lamp power supply causes the flash lamp to light, causing the<br>emission of an invisible infrared Er:YAG laser beam (2.94<br>microns). A visible white light pulsed beam from the flashlamp is<br>used as an aiming beam. The laser beam passes through a<br>partially reflecting mirror and then passes through the energy<br>monitor, after which its power is measured. When all the pre-<br>conditions have been satisfied and the READY button is pressed<br>and the foot switch is depressed, the safety shutter opens and the<br>laser beam is allowed into the delivery unit coupler. | |
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| The electrical system is comprised of the laser power supply, the<br>control unit, calibrator, control panel, key switch, emergency stop<br>switch, and foot switch. The components of the laser power<br>supply include a high voltage power supply and a high voltage<br>trigger control board. The high voltage power supply uses the<br>high voltage to illuminate the flashlamp. The control unit<br>comprises a microprocessor board, accessory board and other<br>components that it controls. The calibrator measures the<br>transmittance of the fiber delivery unit. The handheld scanner<br>module is an attachment to the fiber. | |
| Intended Use: | The DERMASCULPT is intended for Dermatological procedures<br>requiring incision, excision, coagulation and vaporization of soft<br>tissue. The specific indications using the applicable handpieces<br>are as follows: |
| | Skin resurfacing in the treatment of wrinkles and scar<br>revision (including acne scars) with the non-fractionated<br>handpiece. |
| | Removal of cutaneous skin lesions with the micron tip<br>handpieces including epidermal nevi, actinic chellitis,<br>keloids, verrucae, skin tags, anal tags, keratosis, scar<br>revision, (including acne scars), benign tumors and cysts,<br>superficial skin lesions and diagnostic biopsies. |
| | The DERMASCULPT with the fractionated scanner handpiece is<br>intended/indicated for Dermatological procedures requiring<br>coagulation of soft tissue and skin resurfacing. |
| Comparison: | Technical specifications, operating performance features, and<br>general physical configuration: CB Erbium 2.94 (K970934), the<br>VersaWave Dental Laser System (K041710) and the Multilite<br>Erbium:YAG Surgical Laser System (K933057). |
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| | Indications: Fidelis XS (K990243), Multilite Erbium:YAG<br>Surgical Laser System (K933057), Cutera Pearl (K070138),<br>Mosaic Laser System (K070392), Erbium Fractional Handpiece<br>(K071768), Profile Multi-Platform System (K070388), CB<br>Erbium/2.94 (K970934), SmoothPeel (K unknown) Laser Peel,<br>Fraxel SR (K050841). |
| Nonclinical Performance<br>Data: | The review of the technical characteristics, indications for use,<br>mechanism of action, and verification and validation information<br>provided demonstrate that the DermaSculpt is substantially<br>equivalent to its predicate device. |
| Clinical Performance Data: | HOYA ConBio has established that the DermaSculpt performs as<br>clinically intended and that no new issues of safety and<br>effectiveness are introduced. |
| Additional Information: | None requested at this time. |

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0731512

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hoya ConBio, Inc. % Liza Burns and Associates Ms. Liza Burns Regulatory Consultant 19722 Westview Drive Twain Harte, California 95383

AUG 2 7 2008

Re: K073158

Trade/Device Name: DermaSCULPT Er:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 11, 2008 Received: August 25, 2008

Dear Ms. Burns:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Liza Burns

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet, Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or a its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K073158

Device Name: DermaSCULPT Er:YAG Laser System

Intended Use/Indications for Use:

The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows:

Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece.

Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies.

The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K073158